Treatment of Intrauterine Adhesions and Its Distribution of Genital Tract Flora

NCT03731689 | Unknown DMC

• 1 other identifier: Intrauterine adhesions
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the treatment of intrauterine adhesion and the factors influencing its prognosis.

Conditions

Intrauterine Adhesions

Keywords

intrauterine lavage therapy; hysteroscopy; microbiome; uterine endometrial repair; intrauterine gel-injection therapy

Outcome Measures

Primary Outcomes (1)

• Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound

  1 year

Secondary Outcomes (5)

• Menstruation Pattern(Improvement or No Significant Change) of All Participants

  1 year

• Reduction of American Fertility Society adhesion score at Second-look

  one year

• Number of Participants With Pregnancy after operation

  two years

• Differences in distribution of reproductive tract bacteria between patients are before and after operation

  one year

• Differences in distribution of reproductive tract bacteria between healthy control group and intrauterine adhesion patients

  one year

Study Arms (4)

Control group

NO INTERVENTION

Control group( Intrauterine patients) do not apply intrauterine lavage therapy or intrauterine gel-injection therapy after surgery.

Intrauterine lavage therapy group

EXPERIMENTAL

Intrauterine lavage therapy group apply intrauterine lavage therapy after surgery.

Drug: Intrauterine lavage therapy

Intrauterine gel-injection therapy group

EXPERIMENTAL

Intrauterine gel-injection therapy group apply intrauterine gel-injection therapy after surgery.

Drug: Intrauterine gel-injection therapy

Healthy control group

NO INTERVENTION

Healthy control group 1)have regular menstrual cycles,diagnostic hysteroscopy with endometrial biopsy and laparoscopy as part of their infertility diagnostic work-up prior to IVF, hysteroscopy and subsequent pathological results having shown no abnormality in the uterine cavities and abdominal cavity.2) had male partners who were infertile and diagnosed with defective sperm function,such as asthenozoospermia, oligoasthenozoospermia, severe oligoasthenozoospermia and azoospermia, defined according to guidelines published by the World Health Organization.

Interventions

Intrauterine lavage therapy DRUG

Intrauterine lavage treatment was performed within 3 to 7 days after the first menstrual period after surgery.

Intrauterine lavage therapy group

Intrauterine gel-injection therapy DRUG

Intrauterine gel-injection treatment was performed within 3 to 7 days after the first menstrual period after surgery.

Intrauterine gel-injection therapy group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pre-operative adhesion score was ≥5
• The prior menstrual cycle was regular, and the sex hormone was normal
• Patients had fertility requirement
• Male semen examination showed normal
• There were no severe systemic diseases, and no contradictions to aspirin, estrogen and surgery
• regular menstrual cycles,diagnostic hysteroscopy with endometrial biopsy and laparoscopy as part of their infertility diagnostic work-up prior to IVF, hysteroscopy and subsequent pathological results having shown no abnormality in the uterine cavities and abdominal cavity
• the healthy women recruited had male partners who were infertile and diagnosed with defective sperm function,such as asthenozoospermia, oligoasthenozoospermia, severe oligoasthenozoospermia and azoospermia, defined according to guidelines published by the World Health Organization.

You may not qualify if:

• Pre-operative adhesion score was \<5
• Prior menstrual cycle was irregular and sex hormone was abnormal, or patients had endocrine factors that caused amenorrhea, menstrual reduction and infertility
• Patients had no fertility requirement
• Patients(experimental group and control group) had male factor infertility
• Patients had contradictions to estrogen and aspirin such as cancers (breast cancer and endometrial cancer), thrombotic diseases, allergy to antipyretic analgesics, severe liver injury, hypoprothrombinemia, vitamin K deficiency, hemophilia, thrombocytopenia, gastric or duodenal ulcer and asthma.
• refuse Endometrial biopsy
• Vaginal discharge abnormal, or suspected vaginitis or pelvic inflammatory disease, or using antibiotics.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Guangzhou

Guangdong, Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Yuqing Chen, Deputy chief

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaling Guo, master

CONTACT

15622327162; 1106561876@qq.com

Yuqing Chen, Deputy chief

CONTACT

13724067575; fangchenyq@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: November 3, 2018
• First Posted: November 6, 2018
• Study Start: May 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 6, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)